FDA.reportPublic FDA data

OBALON® Placebo Capsule

Primary DI
00859810006005
Brand
OBALON® Placebo Capsule
Company
Medtimo, Inc
Model
7150-0003
Device description
OBALON® Placebo Capsule - component for use with the OBALON® Balloon System
Published
2016-12-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LTIImplant, Intragastric For Morbid Obesity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LTIImplant, Intragastric For Morbid ObesityUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P160001000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160001000OBALON BALLOON SYSTEMMedtimo, Inc.2016-09-08LTI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859810006002PackageGS150Not in Commercial Distribution
20859810006009PackageGS15Not in Commercial Distribution
00859810006005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085981000600210859810006002
2085981000600920859810006009
00859810006005008598100060058598100060050859810006005

GMDN Terms#

Term, Definition table
TermDefinition
Appetite-suppression gastric balloonAn implantable device intended to be swallowed or endoscopically inserted into the stomach where it is inflated to reduce stomach volume and facilitate weight loss in overweight/obese patients by restricting the quantity of food consumed through an increased sense of satiety (fullness). It is designed to be inflated/filled with an inert material (e.g., saline, air, nitrogen) in situ, where it remains until it is endoscopically removed or deflates and passes through the bowels. Disposable devices dedicated to introduction/inflation may be included with the balloon.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry, Storage Temperature Limits: 59 to 77 degrees F (15 to 25 degrees C)
Storage Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
1-844-362-2566customerservice@obalon.com

Regulatory Flags#

DUNS number
144843751
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850007764470ReShape Calibration Tubes™B-2017B-20172025-08-01
00850007764258ReShape Calibration TubesB-2032B-20322023-03-16
00850007764265ReShape Calibration TubesB-2036B-20362023-03-16
00850007764272ReShape Calibration TubesB-2040B-20402023-03-16
00850007764203Gastric Balloon Suction Catheter B-2020 B-2020 2020-11-01
00859810006012OBALON® EzFill™ Can8200-00012016-12-22
00859810006050OBALON® Balloon System9500-00012016-12-26
00859810006081OBALON® Placebo Capsule HPMC7650-00022017-07-11
00859810006210OBALON® Inflation Can8200-00012018-07-11
00859810006227OBALON®9410-00012019-02-20
00859810006265Obalon Aspiration Adapter6100-00042018-08-09
00850007764500ReShape Lap-Band® 2.0 FLEX, StandardD-3360D-33602024-01-22
00850007764517ReShape Lap-Band® 2.0 FLEX, LargeD-3365D-33652024-01-22
00850007764548ReShape Lap-Band® 2.0, FLEX & Access Port, StandardD-3304D-33042024-01-22
00850007764555ReShape Lap-Band® 2.0, FLEX & Access Port, LargeD-3306D-33062024-01-22
00850007764586ReShape Lap-Band® 2.0, FLEX Tubing KitD-3500D-35002024-01-22
10850007764323LAP-BAND® System Access Port Needle, 20G x 51 mm (2 in.)B-20302-10B-20302-102021-04-01
10850007764330LAP-BAND® System Access Port Needle, 20G x 89 mm (3.5 in.)B-20301-10B-20301-102021-04-01
00850007764043RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System StandardC-2304C-23042021-02-01
00850007764067RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System LargeC-2306C-23062021-02-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506049232Orbera™BOSTON SCIENTIFIC CORPORATIONLTI2026-06-04
00810010540119Allurion™ Gastric Balloon SystemAllurion Technologies, Inc.LTI2026-04-07
00810010540126Allurion™ Filler KitAllurion Technologies, Inc.LTI2026-04-07
00810010540133Allurion™ StyletAllurion Technologies, Inc.LTI2026-04-07
03665039001663Endoline PUNCPRINCE MEDICALLTI2024-01-30
03665039005630Extraction Kit PRINCE MEDICALLTI2024-01-30
00850007764500ReShape Lap-Band® 2.0 FLEX, StandardMedtimo, IncLTI2024-01-22
00850007764517ReShape Lap-Band® 2.0 FLEX, LargeMedtimo, IncLTI2024-01-22
00850007764548ReShape Lap-Band® 2.0, FLEX & Access Port, StandardMedtimo, IncLTI2024-01-22
00850007764555ReShape Lap-Band® 2.0, FLEX & Access Port, LargeMedtimo, IncLTI2024-01-22
00850007764586ReShape Lap-Band® 2.0, FLEX Tubing KitMedtimo, IncLTI2024-01-22
00860005178803Spatz3 Adjustable Balloon System insertion kit SPATZ FGIA (ISRAEL) LTDLTI2021-10-20
10850007764323LAP-BAND® System Access Port Needle, 20G x 51 mm (2 in.)Medtimo, IncLTI2021-04-01
10850007764330LAP-BAND® System Access Port Needle, 20G x 89 mm (3.5 in.)Medtimo, IncLTI2021-04-01
00850007764043RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System StandardMedtimo, IncLTI2021-02-01
00850007764067RapidPort® EZ Access Port Kit for use with LAP-BAND® AP System LargeMedtimo, IncLTI2021-02-01
00850007764609LAP-BAND® AP System Standard with RapidPort® EZ Medtimo, IncLTI2021-02-01
00850007764654LAP-BAND® AP System Large with RapidPort® EZ Medtimo, IncLTI2021-02-01
00850007764906RapidPort® EZ Port ApplierMedtimo, IncLTI2021-01-01
00850007764173LAP-BAND® System Calibration TubeReShape Lifesciences Inc.LTI2020-12-01
00859810006227OBALON®Medtimo, IncLTI2019-02-20
00859810006104OBALON Touch™ Medtimo, IncLTI2019-02-20
00859810006142OBALON®Medtimo, IncLTI2019-02-20
00859810006173OBALON®Medtimo, IncLTI2019-02-20
00859810006180OBALON®Medtimo, IncLTI2019-02-20
00859810006197OBALON®Medtimo, IncLTI2019-02-20
00859810006203OBALON Touch™Medtimo, IncLTI2019-02-20
10859810006224OBALON®OBALON THERAPEUTICS, INC.LTI2019-02-20
00859810006234OBALON®Medtimo, IncLTI2019-02-20
00859810006241OBALON®Medtimo, IncLTI2019-02-20